An Evaluation of Potential Next-day Residual Effects of Eszopiclone in Healthy Volunteers.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Sleep Initiation and Maintenance Disorders; Healthy Subjects

Treatments: Drug: GSK1755165; placebo; zopiclone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00699608

ESZ111503

Details and patient eligibility

About

This study will explore potential next-day residual effects of a single evening dose of 3mg of the hypnotic, eszopiclone, 7.5mg of zopiclone, and placebo, in healthy adult subjects.

Enrollment: 91 patients

Sex: All

Ages: 25 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female subjects providing written informed consent.

Exclusion criteria

• Significant medical disorders;
• Sleeping difficulties; alcohol and/or substance abuse;
• Recent use of psychotropic medications, or need to use them during study;
• Very high BMI or very low BMI or bodyweight;
• Known hypersensitivity to the study medications or their excipients;
• Unwilling or unable to meet certain lifestyle or dietary restrictions during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

91 participants in 1 patient group

Crossover

Experimental group

Description:

All subjects received all three treatments in a randomised order

Treatment:

Drug: GSK1755165; placebo; zopiclone